Major Depressive Disorder (MDD)NCT07771517
Role of Kynurenine Pathway and Its Metabolites in Depressive Disorders, Major Depressive Disorder is Suspected to Have the Greatest Burden by 2030,Kynurenine Pathway is Major Route Through Which the Essential Amino Acid Tryptophan is Metabolised and Activated in Time of Stress and Immune Activation.
An observational study of Major Depressive Disorder (MDD), run by Sohag University.
Trial summary
This is a case control study including simple random cases of 90 persons, 45 of them have depressive disorders and the other 45 are healthy individuals,age group between 18-60 years old, cases will be recruited from outpatient psychiatric clinic in sohag university hospital, all cases will be exposed to psychological… Read more about this study
- Who is it for?
- Ages 18 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder (MDD)
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 14 Mar 2027to 20 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 18 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with age group between 18: 60 years old and all cases are drug free of at least 4 months
Who may be able to join
- age group 18: 60 years old
- cases are drug free of at least 4 months
Who cannot join
- patients with comorbid other psychiatric disorders( SUD,anxiety)
- patients with IQ below 90
- patients with psychotic features
- patients with postpartum depression
- patients with chronic medical illness that might affect immune function
- patients under treatment with immune modulating therapy
About this study
Official title: Role of Kynurenine Pathway and Its Metabolites in Depressive Disorders
This is a case control study including simple random cases of 90 persons, 45 of them have depressive disorders and the other 45 are healthy individuals,age group between 18-60 years old, cases will be recruited from outpatient psychiatric clinic in sohag university hospital, all cases will be exposed to psychological assessment and also laboratory assessment of kynurenine metabolites by using biokits
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- Kynurenine pathway, MDD, Kynurenine pathway in depressive disorders, Depressive disorder, Bipolar disorder, Role of kynurenine pathway and its Metabolites in depressive disorders
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder, Bipolar Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological assessment of patients with depressive disorders
All cases will be subjected to psychological assessment by using structured clinical interview for DSM-V to assess major depressive disorder,bipolar and other depressivedisorders, Hamilton depression rating scale HAN-D to assess MDD, Hamilton anxiety inventory HAM-A to assess anxiety disorders, Montreal cognitive assessment to assess cognitive functions, Pittsburg sleep quality index to assess quality of sleep and detailed family history will be obtained to assess possibility of genetic factors in health relatives to patients with depressive disorders.
Measured: From the enrollment of all cases till three months later
Detect abnormalities in kynurenine pathway in patients with depressive disorders
Blood samples will be collected from patients and healthy control cases in microbiology laboratory in Sohag university hospital; by using biokits for kynurenine to measure kynurenine level in nanomolar to low micromolar in liter, Add a tryptophan measure outcome to measure tryptophan level in micromol per liter Add a quinolinic acid measure outcome to measure quinolinic acid level in microgram per milliliter by ELISA
Measured: From the time of enrollment till 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start14 Mar 2027 (estimated)
- Primary completion20 Aug 2028 (estimated)
- Study completion20 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Abdelsamie Asaad, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771517
- Sponsor's protocol ID
- Soh-Med--26-7-2MD
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Kynurenine Pathway and Its Metabolites in Depressive Disorders
- ClinicalTrials.gov ID
- NCT07771517
- Acronym / sponsor ID
- Soh-Med--26-7-2MD
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- Kynurenine pathway, MDD, Kynurenine pathway in depressive disorders, Depressive disorder, Bipolar disorder, Role of kynurenine pathway and its Metabolites in depressive disorders
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 14 Mar 2027 (estimated)
- Primary completion
- 20 Aug 2028 (estimated)
- Study completion
- 20 May 2029 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a case control study including simple random cases of 90 persons, 45 of them have depressive disorders and the other 45 are healthy individuals,age group between 18-60 years old, cases will be recruited from outpatient psychiatric clinic in sohag university hospital, all cases will be exposed to psychological assessment and also laboratory assessment of kynurenine metabolites by using biokits
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with age group between 18: 60 years old and all cases are drug free of at least 4 months
Key inclusion criteria (2 listed)
- age group 18: 60 years old
- cases are drug free of at least 4 months
Key exclusion criteria (6 listed)
- patients with comorbid other psychiatric disorders( SUD,anxiety)
- patients with IQ below 90
- patients with psychotic features
- patients with postpartum depression
- patients with chronic medical illness that might affect immune function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Psychological assessment of patients with depressive disorders
Time frame: From the enrollment of all cases till three months later
All cases will be subjected to psychological assessment by using structured clinical interview for DSM-V to assess major depressive disorder,bipolar and other depressivedisorders, Hamilton depression rating scale HAN-D to assess MDD, Hamilton anxiety inventory HAM-A to assess anxiety disorders, Montreal cognitive assessment to assess cognitive functions, Pittsburg sleep quality index to assess quality of sleep and detailed family history will be obtained to assess possibility of genetic factors in health relatives to patients with depressive disorders.
Detect abnormalities in kynurenine pathway in patients with depressive disorders
Time frame: From the time of enrollment till 3 months later
Blood samples will be collected from patients and healthy control cases in microbiology laboratory in Sohag university hospital; by using biokits for kynurenine to measure kynurenine level in nanomolar to low micromolar in liter, Add a tryptophan measure outcome to measure tryptophan level in micromol per liter Add a quinolinic acid measure outcome to measure quinolinic acid level in microgram per milliliter by ELISA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder (MDD), run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological assessment of patients with depressive disorders (time frame: From the enrollment of all cases till three months later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.